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The Effect of Ketamine on Interleukin-6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978757
First Posted: September 17, 2009
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Italiano de Buenos Aires
  Purpose
The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.

Condition Intervention Phase
Hepatectomy Drug: Ketamine Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 4: Study of Ketamine Inhibition of Interleukin 6 in Hepatic Resections Requiring Temporary Porto-arterial Occlusion

Resource links provided by NLM:


Further study details as provided by Hospital Italiano de Buenos Aires:

Primary Outcome Measures:
  • The Effect of Ketamine on Interleukin 6 Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver) [ Time Frame: Blood samples for IL-6 levels were obtained prior to surgery, upon placement of the first intravenous ]

Enrollment: 42
Study Start Date: June 2001
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
Drug: Ketamine
Ketamine: 0.25 mg/kg, intravenously, one dose.
Other Name: Ketamine commercially available - FADA Pharma
Placebo Comparator: Placebo
Placebo: saline solution
Other: Placebo
saline solution
Other Name: Normal saline

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 21 or older
  • Planned liver resection with Pringle maneuver lasting 30-60 minutes

Exclusion Criteria:

  • Chronic illness requiring corticosteroids
  • Cirrhosis
  • Hemodynamic instability prior to surgery
  • Diabetes
  • Sepsis
  • Surgical interventions or chemotherapy treatments within the past 30 days
  • Pregnancy
  • Illnesses that could potentially affect the hepatic circulation
  • Arterial hypertension
  • Ocular hypertension
  • Allergy to ketamine
  • Preoperative portal embolization
  • Radiofrequency ablation
  • Patients requiring emergency surgeries
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978757


Locations
Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, Argentina, 1181
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
Principal Investigator: Francisco C Bonofiglio, MD PhD Hospital Italiano of Buenos Aires, Argentina
  More Information

Responsible Party: Hospital Italiano of Buenos Aires, Argentina
ClinicalTrials.gov Identifier: NCT00978757     History of Changes
Other Study ID Numbers: IRB#556
First Submitted: September 16, 2009
First Posted: September 17, 2009
Results First Submitted: September 23, 2009
Results First Posted: January 18, 2010
Last Update Posted: January 18, 2010
Last Verified: October 2009

Keywords provided by Hospital Italiano de Buenos Aires:
hepatectomy
IL 6
organ failure
ketamine
Pringle

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action